Top Regulatory Affairs Executive jobs in Brownsville, TX

Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Brownsville, TX FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.

    Our approximately 7,000 employees are united around our mission of improving peoples lives with our health care products.

    The Executive Director of Advertising & Promotion- Regulatory Affairs prescription drug products manages and, if required participates in, the reviews and approvals of advertising and promotional labeling pieces for prescription drugs. The Executive Director is responsible for ensuring the pieces are in compliance with regulatory agencies requirements.

    Responsibilities:

    • Manages the Regulatory Promotional reviews for prescription drugs who represent Regulatory Affairs on the promotional review committee for marketed products. This position may require reviewing promotional materials if the company requires it. This person is responsible for compliance with regulatory requirements while meeting Company's strategic promotional objectives.

    • Provide guidance on proposed claims for products in development and development of ISI and brief summaries.

    • Regularly monitor the regulatory compliance trends in industry, interpret new regulations, guidance documents and enforcement letters. Update the Regulatory Ad Promo staff, review committees and appropriate other company staff regarding changes in the current regulatory environment at FDA's Office of Prescription Drug Promotion (OPDP) and other regulatory considerations that may impact business. Develop or revise procedures as needed.

    • Review packages for regulatory advice, resolution of FDA action letters and leads the company in discussions with OPDP.

    • Coordinate companywide ongoing regulatory training on regulatory issues pertaining to promotion of Company products.

    • Represents regulatory affairs in cross functional prescription product promotional review teams as required, participate in development committees for processes and procedures relating to ad promo.

    • Interacts with Quality related to internal audits and CAPAs, as needed.

    Qualifications:

    • Bachelor Degree in science or health related discipline required (Advanced degree PhD, MD, MS, PharmD preferred)

    • 12 years of pharmaceutical experience with 10 years of regulatory affairs product advertising and promotion experience required.

    • GI experience strongly preferred

    • Broad knowledge of the pharmaceutical industry. Demonstrated ability to contribute to a continuous learning and process improvement environment.

    • Detail-oriented with the ability to promptly assess documents for accuracy as well as consistency

    • Strong interpersonal skills with the ability to influence others in a positive and effective manner

    • Ability to work in a team environment

    • Working knowledge of Rx NDA development and approval process

    • Excellent communication skills; both oral and written

    As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is 280K – 320K.

    Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, 3-weeks paid time off plus 6 days paid sick time (unless a state or city-specific policy applies) to start (pro-rated for new hires), tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, 12 paid holidays (including floating holidays), Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.

    This position may be available in the following location(s): [[location_obj]]

    We thank you in advance for your interest in growing and developing with Bausch Health. Kindly note that in order for all stakeholders to be successful, we do require a minimum of one year in your current role before applying to another one. Please ensure you have discussed with your current manager the intent of applying to a new role.

    Any exception will have to be authorized by your HR Business Partner.

    Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

    If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.

    Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

    To learn more please read Bausch Health's Job Offer Fraud Statement (https://protection.greathorn.com/services/v2/lookupUrl/c29afa19-107c-4ce0-9f8c-cdaacd1f6318/176/379301a79c224eae9f25e08c7426cedde0ec4807) .

    Bausch Health is an EEO/AA employer M/F/D/V.

  • 11 Days Ago

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Administrative Support Assistant (OA)
  • US Executive Office for U.S. Attorneys and the...
  • Brownsville, TX FULL_TIME
  • Duties As an Administrative Support Assistant in the United States Attorney's Office (USAO), you will: Uses office automation processing software and equipment in performing management and/or program ...
  • 11 Days Ago

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Assistant United States Attorney
  • Executive Office for U.S. Attorneys and the Office of the U.S. Attorneys
  • Brownsville, TX FULL_TIME
  • The U.S. Attorney's Office for the Southern District of Texas is among the busiest and largest in the nation, spanning 43 counties and 44,000 square miles and representing 8.3 million people from the ...
  • 23 Days Ago

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Account Executive
  • UniTrust Financial Group
  • Brownsville, TX FULL_TIME
  • Insurance Account Executive Location: Remote (Virtual Work From Home) Work Hours: Flexible Hours, Full-Time Only About InsuraTec Services Group: InsuraTec Services Group is a leading provider of finan...
  • 1 Month Ago

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Executive Chef
  • Margaritaville Resort SouthPadre
  • South Padre Island, TX FULL_TIME
  • Job Summary The Executive Chef is responsible for supervising and assisting in the preparation of all food items based on standardized recipes for the Restaurant Room Service Employee Cafeteria and Ba...
  • Just Posted

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Executive IT Support Specialist
  • SpaceX
  • Brownsville, TX FULL_TIME
  • SpaceX was founded under the belief that a future where humanity is out exploring the stars is fundamentally more exciting than one where we are not. Today SpaceX is actively developing the technologi...
  • 21 Days Ago

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0 Top Regulatory Affairs Executive jobs found in Brownsville, TX area

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Area Manager
  • Bechtel Corporation
  • Brownsville, TX
  • **Requisition ID: 274598** + **Relocation Authorized: National - Family** + **Telework Type: Full-Time Office/Project** ...
  • 3/29/2024 12:00:00 AM

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Housekeeper - PRN- Days
  • Dhr Rgv
  • Brownsville, TX
  • **Description** *Position at DHR Health* **POSITION SUMMARY****:** To provide routine manual services to assure clean, o...
  • 3/29/2024 12:00:00 AM

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Director of Quality Management Full Time Days
  • Tenet Healthcare Corporation
  • Harlingen, TX
  • Summary The individual in this position is a key member of the hospital management team, and provides leadership and ove...
  • 3/29/2024 12:00:00 AM

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Remote Sales Representative - Work From Home
  • Symmetry Financial Group
  • Brownsville, TX
  • Job Description Overview: We are seeking a highly motivated and results-driven Life Insurance Sales Representative to jo...
  • 3/28/2024 12:00:00 AM

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Biomedical Equipment Support Specialist - OCA
  • U.S. Food and Drug Administration
  • Harlingen, TX
  • ** Biomedical Equipment Support Specialist - OCA** **Department of Veterans Affairs** ** Texas Valley Costal Bend VA Hea...
  • 3/28/2024 12:00:00 AM

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Logistics Manager (RGV)
  • GOODWILL INDUSTRIES OF SOUTH TEXAS INC.
  • Harlingen, TX
  • Description SUMMARY OF POSITION: The Manager of Logistics is responsible for the entire life cycle for agency merchandis...
  • 3/28/2024 12:00:00 AM

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Career Services Coach
  • Advatix - Advanced Supply Chain And Logistics
  • Weslaco, TX
  • Career Services Coach Role Summary Our client seeks a Career Services Coach to join their rapidly growing team. The Care...
  • 3/28/2024 12:00:00 AM

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Physician II -P/T- Outpatient Clinic
  • Texas Health & Human Services Commission
  • Harlingen, TX
  • Physician II - P/T, Outpatient Clinic Would you thrive in an environment where you learn and grow personally and profess...
  • 3/26/2024 12:00:00 AM

Brownsville is one of the southernmost cities in the contiguous United States; only a handful of municipalities in Florida's Miami-Dade and Monroe counties (plus Everglades City in Collier County) are located farther south than Brownsville. The city has a total area of 84.867 square miles (219.805 km2), of which 81.528 square miles (211.157 km2) of it is land and 3.339 square miles (8.648 km2) is water, according to the United States Census Bureau of 2017. The city is situated at the intersection of different climates (subtropical, Chihuahuan Desert, Gulf Coast plain, and Great Plains); this p...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$255,661 to $418,276
Brownsville, Texas area prices
were up 1.2% from a year ago

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